Who is eligible for clinical trial NCT04802603?

Participants must meet protocol criteria for Spine Metastases. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04802603 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-11-13

Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column (NCT04802603)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Baptist Health South Florida

🩺 Plain-English Summary (8th-Grade Level)

This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques. In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (8 items).

Location: Miami Cancer Institute at Baptist Health, Inc — Miami, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Zubrod Performance Status 0-2
Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)
Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
Non-ambulatory patients
\>50% loss of vertebral body height or spinal instability to due pathologic compression fracture
Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
Rapid neurologic decline
Patients for whom an MRI of the spine is medically contraindicated
Pregnant women

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Miami Cancer Institute at Baptist Health, Inc — Miami, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗